When the sponsor of a multi-site study does not identify a "central" IRB for the included investigators to utilize, the investigators may elect to submit to E&I for review and approval of their "single-site" milfs
participation in the project. This section will assist investigators wishing to submit to E&I for approval of study conduct as a single-site.

[G] indicates a link to more information about a requirement. Additional guidance can be obtained under the Guidance menu on the website.

Although the investigator is not the sponsor in this type of submission, in a single-site study the IRB's relationship is solely with the investigator. In single-site studies, the investigator (prior to beginning any study related activities) is responsible for obtaining IRB approval of the study in addition to gaining approval for their participation as the Principal Investigator.

In some cases, review by the full board may not be required for study conduct approval. When the proposed protocol is determined to be less than minimal risk, and qualifies under one of seven specific regulatory criteria categories, the study may be determined eligible for review by an expedited review[G] process. If you believe your study may qualify under the applicable regulatory requirements for expedited review, and would like your project reviewed utilizing this process, you will be asked to submit an E&I Request for Expedited Process (Form 22) as part of the Study Application Form. E&I is always willing to discuss the specifics of any given study to assist an Investigator in determining what their review needs are in accordance with the regulations.

There are many different types of projects that an investigator may wish to take part in. The type of information the board will need to perform their review is directly related to the type of study the investigator will be conducting. E&I specializes their application forms into two types, clinical and non-clinical research.

The IRB has a regulatory obligation to consider the local perspective of where the study will take place. As part of this consideration the board will determine whether or not the investigator's training and experience qualifies them to perform the designated functions required by the design of the study. Before approving an investigator, the board must first obtain relevant information about the individual and their location. This information is typically requested in a PI application form (also referred to as a submission or cover form.)

For Clinical (Drug and/or Device) Research Submissions for review of these types of studies typically include a clinical investigation of a product or device and usually fall under the regulatory requirements of the FDA. These studies are often designed to test safety or efficacy of a product.

For Non-Clinical (Social, Behavioral, Educational) Research These types of projects typically do not test safety or efficacy of a product, but may at times involve products or devices in their design. Often non-clinical research will fall under the regulatory guidance of OHRP (link to 45 part 46), which varies slightly from FDA regulatory language.